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RecruitingNCT05558644IMMUNO-TETUpdated Jul 10, 2026

Characterisation of the Immune Infiltrate and Molecular Features of Thymic Epithelial Tumors Tumors (TETs)

An interventional study of single arm for all patients in Cancer, sponsored by Institut Curie. Recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by Institut Curie · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The IMMUNO-TET trial aims to assess the feasibility of characterising the immune environment of TETs and the constitutional and somatic molecular profiles of patients with localised thymic epithelial tumour (TET).

Read the detailed description

In this prospective study, patients undergoing thymectomy and thymomectomy as part of routine care undergo the following care pathway:

  1. During the pre-surgical visit (for n = 50 patients): as part of routine care, a blood sample is collected for analysis of CBC, leukocytes, lymphocytes, CRP, ferritinemia, TSH, T3L, T4L, anti-acetycholine receptor antibodies, …CMV, EBV, HSV, HIV serologies, …and HLA class I and class II typing.
  2. During thymectomy and thymomectomy surgery, the following samples are taken (for n = 50 patients):

    • 6 blood samples on EDTA tubes are collected at the time of surgery for analyses.
    • 3 fresh samples of the surgical specimen are taken by the pathologist: tumour T, juxta-tumour J and distant D locations for analyses by flow cytometry and RNA sequencing. Anatomopathology blocks/slides are also cut in the same way (tumour T, juxta-tumour J and distant D locations) for additional exploratory analyses.
    • The feasibility of developing patient-derived xenografts (PDX) from TETs will be tested for n = 20 tumor samples. These models will allow to test potential therapeutic agents for this pathology.
  3. During the 1st month (+/- 7 days) post-surgery check-up, a blood sample is taken again (for n = 50 patients) for routine care: CBC, leukocytes, lymphocytes, CRP, ferritinemia, anti-acetycholine receptor antibodies and for peripheral immune system analysis at a distance from surgery and for constitutional molecular analysis.

Informed consent is given to participate in this prospective study.

02

Conditions studied

  • Cancer

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Keywords

  • thymic epithelial tumors
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient with suspicion of localised thymic epithelial tumour.
  2. Age ≥ 18 years.
  3. Treatment-naïve patient for this disease.
  4. Patient with an indication for thymectomy and thymomectomy in one of the partner centers.
  5. Signed informed consent form of the patient.

Exclusion criteria

Exclusion Criteria:

  1. Neoadjuvant chemotherapy.
  2. No social security affiliation.
  3. Person under legal protection.
  4. Other neoplasia in progress or cured within the last 3 years (except for operated carcinoma in situ).
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    single arm for all patients

    single arm for all patients tumor samples will be taken for RNA sequencing of epithelial tumour cells during surgery. blood samples will be taken for Exome Sequencing (WES) at baseline, during surgery and one month post surgery.

    Other: single arm for all patients

Interventions

  • Othersingle arm for all patients

    * tumor samples will be taken for RNA sequencing of epithelial tumour cells during surgery. * blood samples will be taken for Exome Sequencing (WES) at baseline, during surgery and one month post surgery.

05

What researchers measure

Primary outcomes

  1. Somatic molecular characterisation of TETs

    Description of genetic abnormalities in thymic tumours compared to non-tumourous thymic tissue (Whole Exome Sequencing RNA-sequencing technique, DNA Optical mapping);

    Time frame: 38 months

  2. Characterisation of the immune environment of TETs

    Description of immune cells in the tumour environment, description of tumour infiltrating T cells

    Time frame: 38 months

  3. Molecular characterisation of TETs

    Molecular constitutional characterisation of TETs with the technique of the Exome Sequencing (WES) on blood samples of patients with TETs

    Time frame: 38 months

Secondary outcomes

  1. Genomic characterisation of TETs

    WES data analysis constitutional genetic alterations will be performed.

    Time frame: 38 months

  2. Characterisation of potential alterations in signalling pathways to identify potential therapeutic targets

    Molecular analyses will be performed to identify potential alterations in signalling pathways that can be targeted by new therapies.

    Time frame: 38 months

  3. Identification of potential neoepitopes

    Analysis of TETs single-cell RNA-seq data will be performed.

    Time frame: 38 months

  4. Transcriptomic characterisation of TETs

    Transcriptome sequencing analysis will be performed.

    Time frame: 38 months

  5. Epigenetic characterisation of TETs

    Epigenetic characterisation of TETs will be performed by molecular analyses.

    Time frame: 38 months

06

Study locations

3 of 3 sites recruiting
  • Institut Curie Paris
    Paris, France
    Recruiting
  • Institut Mutualiste Montsouris
    Paris, France
    • Alessio MARIOLO, MD · Contact
    • Alessio MARIOLO, MD · Principal investigator
    Recruiting
  • Hôpital FOCH
    Suresnes, France
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05558644
Lead sponsor
Institut Curie
Responsible party
Sponsor
First posted
Sep 28, 2022
Start date
Aug 3, 2023
Primary completion
Oct 2, 2028 (estimated)
Completion
Oct 2, 2029 (estimated)
Last update
Jul 10, 2026

Study contacts

Nicolas GIRARD, MD
Contact
nicolas.girard2@curie.fr
0156245539
Nicolas GIRARD, MD
study director · Institut Curie Paris

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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